Travere Therapeutics
Travere Therapeutics is a biopharmaceutical company committed to identifying, developing, and delivering life-changing therapies for people living with rare diseases, particularly those related to rare kidney and metabolic disorders. The company has a strong focus on advancing science in these fields, with a pipeline that includes treatments for conditions such as IgA nephropathy and focal segmental glomerulosclerosis. With the full U. S. FDA approval of its non-immunosuppressive treatment for IgA nephropathy, Travere Therapeutics continues to set new standards of care. The company collaborates with the rare kidney disease community, including patient advocacy organizations and clinical trial investigators, to bring hope to patients with these serious conditions.
Executive Director - Regulatory Affairs
February 19
Travere Therapeutics
Travere Therapeutics is a biopharmaceutical company committed to identifying, developing, and delivering life-changing therapies for people living with rare diseases, particularly those related to rare kidney and metabolic disorders. The company has a strong focus on advancing science in these fields, with a pipeline that includes treatments for conditions such as IgA nephropathy and focal segmental glomerulosclerosis. With the full U. S. FDA approval of its non-immunosuppressive treatment for IgA nephropathy, Travere Therapeutics continues to set new standards of care. The company collaborates with the rare kidney disease community, including patient advocacy organizations and clinical trial investigators, to bring hope to patients with these serious conditions.
📋 Description
• Develop and execute global regulatory strategic and tactical guidance for innovative new drugs in rare disease • Manage interface with outside regulatory agencies and trade associations • Accountable for the preparation, submission and maintenance for product specific dossiers • Negotiate with regulatory authorities and respond to regulatory authority queries • Collaborate with internal stakeholders to define or develop registration documents • Recruit, develop, manage an effective regulatory team
🎯 Requirements
• Bachelor’s degree in a scientific discipline • 12+ years of increasing Regulatory Affairs experience and responsibility • Proven success with product registrations, rare disease development highly desirable • 6+ years of supervisory/management experience in biotech or Pharmaceutical industry • Demonstrated track record of successful approvals from a major regulatory agency is required • Prior regulatory agency liaison experience is essential • Excellent written and communication and interpersonal skills
🏖️ Benefits
• premium health, financial, work-life and well-being offerings for eligible employees and dependents • wellness and employee support programs • life insurance • disability • retirement plans with employer match • generous paid time off
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